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Regulatory Approvals

70cc SynCardia temporary Total Artificial Heart (TAH-t)

Bridge to Transplant Indication: For use as a bridge to donor heart transplant in cardiac transplant-eligible candidates at risk of imminent death from end-stage biventricular failure.

North America:SynCardia temporary Total Artificial Heart

Europe:

HUD for Destination Therapy

The U.S. Food and Drug Administration (FDA) has approved a Humanitarian Use Device (HUD) designation for the SynCardia Total Artificial Heart to be used for destination therapy. ›› See Investigational Use Studies


50cc SynCardia Total Artificial Heart

Europe:

  • CE Mark

United States:


Drivers that Power the SynCardia Total Artificial Heart

Companion 2 Hospital Driver

Front view of the Companion 2 driver

  • European CE Mark: July 25, 2011
  • FDA approval: July 5, 2012
  • Health Canada: Oct. 29, 2013 
    ›› Learn more

 


Freedom® Portable Driver

SynCardia's Systems, Inc. Freedom® portable driver, approved by the FDA, is attached to the SynCardia Total Artificial Heart by two lines. The 13.5-pound driver provides precisely calibrated pulses of air and vacuum to the SynCardia Heart.

  • European CE Mark: March 1, 2010
  • Health Canada: May 25, 2011
  • FDA approval: June 26, 2014
    ›› Learn more

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